# FDA 483 - Neocis Inc. - August 05, 2022

Source: https://www.globalkeysolutions.net/records/483/neocis-inc/1296de71-8311-47c8-ae7b-ad99c1c7361f

> FDA 483 for Neocis Inc. on August 05, 2022. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Neocis Inc.
- Inspection Date: 2022-08-05
- Product Type: device
- Office Name: Office of Medical Device and Radiological Health Division II
- Summary: An FDA inspection of Neocis Inc., a specification developer in Miami, FL, revealed significant deficiencies in their corrective and preventive action (CAPA) procedures. The firm failed to establish effective CAPA processes, resulting in multiple instances where CAPAs were closed as effective but the underlying issues, such as mislabeling, product registration difficulties, and equipment leaks, recurred or remained unresolved. This indicates a systemic breakdown in the company's ability to address and prevent quality problems.

## Related Officers

- [Nydia E. Colon](https://www.globalkeysolutions.net/people/nydia-e-colon/c5137ded-6ae7-4855-b5b3-113bd851e1c3)

Company: https://www.globalkeysolutions.net/companies/neocis-inc/fe1623b5-fea1-4c8b-9256-245c3b6ec81c

Office: https://www.globalkeysolutions.net/offices/office-of-medical-device-and-radiological-health-division-ii/ae9bd439-479a-420d-9dd8-9fe1fc0863d6